Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06754228

Acute Immune Modulation by Probiotic Strain

Led by Natural Immune Systems Inc · Updated on 2024-12-31

24

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

N

Natural Immune Systems Inc

Lead Sponsor

J

Jeneil Biotech Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.

CONDITIONS

Official Title

Acute Immune Modulation by Probiotic Strain

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults
  • Age 18 to 75 years inclusive
  • Veins easy to see in one or both arms to allow multiple blood draws
  • Willing to maintain consistent diet and lifestyle throughout the study
  • Willing to eat bland breakfasts on clinic visit days
  • Willing to abstain from exercise and nutritional supplements on study visit mornings
  • Willing to avoid coffee, tea, and soft drinks for at least one hour before clinic visits
  • Willing to avoid music, candy, gum, and computer or cell phone use during clinic visits
Not Eligible

You will not qualify if you...

  • Previous major gastrointestinal surgery (minor surgery like appendix or gall bladder removal allowed)
  • Taking daily anti-inflammatory medications
  • Experiencing intense stressful events or life changes
  • Engaged in intensive athletic training such as marathon running
  • Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
  • Having an unusual sleep routine (e.g., working graveyard shifts, irregular late nights)
  • Unwilling to keep supplement intake constant during the study
  • Anxiety about having blood drawn
  • Pregnant, nursing, or trying to become pregnant
  • Known food allergies to ingredients in the test product or placebo

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NIS Labs

Klamath Falls, Oregon, United States, 97601

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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